Adhesives and sealants have been contemplated to supplement or replace staple based transaction devices for many years. The primary challenges in accomplishing this are control of getting the adhesive into the correct location at the correct time as well as preventing it from adhering the stapler itself to the treatment site. Adhesives have proven themselves as great short term bonding/sealing mechanisms. In Europe, some surgeons prefer absorbable fasteners over non-absorbable fasteners such as staples. It would be advantageous to form or create fasteners from adhesive at the surgical site and more advantageous if the adhesive that was used to create the surgical fastener was absorbable.
One challenge in the creation of an adhesive fastener is the positioning of the adhesive into tissue and the forming of a fastener from adhesive.
Adhesives have been used topically as a short term fastener for wound repair. Closure Medical has developed a 2-octyl cyanoacrylate compound with a long carbon chain (eight carbons) that is biocompatible, has good bonding strength, and has received FDA approval for topical use. For short duration topical wound closure, the edges of the wound are brought together and at least one layer of the adhesive is applied along the surface of the wound line to form a barrier that holds the wound edges together. The cyanoacrylate adhesive also acts as a microbial barrier, keeping bacteria out and is eventually removed. Cyanoacrylate adhesives are described in United States Application 20040190975 by Goodman et al. which is herein incorporated by reference in its entirety.
Closure Medical is conducting an FDA clinical trial using a cyanoacrylate adhesive as an internal vascular tissue sealant and internal surgical adhesive. Some adhesives such as the cyanoacrylates, stick well to tissue. Additionally, the adhesives can be biocompatible, bioabsorbable, and/or flexible, inside the body.
Consequently, a significant need exists for a surgical fastening device that can use an adhesive to form one or more surgical fasteners, the one or more adhesive fasteners can fasten two portions of tissue together, can pin one or more portions of tissue together, can hold folded tissue together, can encapsulate a vascular or luminal structure, can fill a vascular or luminal structure with an adhesive fastener, and can be formed from an absorbable adhesive.